Cleared Traditional

K261800 - Helo Max Thrombectomy System (HEL2090)

K261800 is an FDA 510(k) clearance for Helo Max Thrombectomy System (HEL2090), manufactured by Endovascular Engineering. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K261800 · Endovascular Engineering · Cardiovascular device
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Sep 2026
Decision
94d
Days
Class 2
Risk

K261800 is an FDA 510(k) clearance for the Helo Max Thrombectomy System (HEL2090). Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Endovascular Engineering (Menlo Park, US). The FDA issued a Cleared decision on September 3, 2026 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Endovascular Engineering devices

FDA 510(k) Submission Details - K261800

510(k) Number K261800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2026
Decision Date September 03, 2026
Days to Decision 94 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEW Device Classification - Class 2, Special Controls

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 143
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K261800.
Triever Duo Catheter
K253419 · Inari Medical, Inc. · Sep 2026
Artix™ MT
K262538 · Inari Medical, Inc. · Aug 2026
Vertex™ Thrombectomy System
K261523 · Jupiter Endovascular · Aug 2026
INDIGO® Aspiration System – INDIGO Link
K260599 · Penumbra, Inc. · Apr 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · Penumbra, Inc. · Feb 2026
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister
K260028 · Argon Medical Devices, Inc. · Feb 2026